Cleared Traditional

VOCO Retraction Paste

K213149 · Voco GmbH · Dental

Dec 2021

Decision

73d

Days

—

Risk

About This 510(k) Submission

K213149 is an FDA 510(k) clearance for the VOCO Retraction Paste, a Cord, Retraction, submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on December 9, 2021, 73 days after receiving the submission on September 27, 2021. This device falls under the Dental review panel.

Submission Details

510(k) Number	K213149 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2021
Decision Date	December 09, 2021
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement